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FDA Accepts Shire’s BLA

For Calaspargase Pegol (Cal-PEG; SHP663) for the treatment of patients with acute lymphoblastic leukemia

The U.S. Food and Drug Administration (FDA) has accepted Shire’s Biologics License Application (BLA) for Calaspargase Pegol (Cal-PEG; SHP663). The investigational-stage compound is being reviewed as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2018 for Cal-PEG.   Shire is developing SHP663 based on more than a decade o...

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